Phase II Study of Genasense-Carboplatin-Paclitaxel-combination in Uveal Melanoma
Sapna P. Patel
The goal of this clinical research is to learn if the combination of Genasense (oblimersen), carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety of this combination will also be studied.
Disease Group: Melanoma
Treatment Agent: Carboplatin,Genasense,Paclitaxel
Treatment Location: Only at MD Anderson
Sponsor: Genta Inc.
Primary Objectives: a. To evaluate objective response rate of patients with metastatic uveal melanoma to Genasense-Carboplatin-Paclitaxel (GCP) combination Secondary objectives: a. To evaluate the overall survival, time to progression, time to treatment failure, and duration of response. b. To evaluate the safety profile of GCP combination in this patient population. c. To correlate response to GCP combination to blood and tumor markers
IRB Review and Approval Date: 12/06/2010
Recruitment Status: Not Accepting
Projected Accrual: N/A
1) Patients must have a history of uveal melanoma and documented
2) Patients must have at least one measurable lesion as per revised RECIST Criteria. A measurable lesion is defined as a non-nodal lesions that is >/= 10 mm provided the CT slice is </=5 mm in thickness or a pathologic lymph node that is >/= 15 mm on the short axis provided the CT slice is </= 5 mm in thickness or Superficial skin lesion that is >/= 10 mm in diameter as assessed using calipers. Bone lesions are not considered measurable.
3) Patients may be previously untreated or may have received prior systemic therapy but no more than one systemic cytotoxic chemotherapy regimen and one targeted therapy for metastatic disease.
4) At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during therapy. If progression occurred during therapy, patient must have recovered from any side effects before starting GCP therapy.
5) At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow.
6) Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
7) Patients must have ECOG performance status of 0 - 2.
8) Patients should be 18 years of age or older.
9) Patients must have adequate liver and renal function as defined by total bilirubin </=1.5 mg/dl, serum Lactate Dehydrogenase level no higher than 2.0 x UNL of the institution, transaminase (i.e., ALT and AST) levels no higher than 5 x UNL and serum creatinine </=1.5 mg/dl or estimated Creatinine Clearance >/=60 ml/min
10) Patients must have adequate bone marrow function as defined by an absolute neutrophil count of greater or equal to 1,500/mm3, and platelet count of greater or equal to 100,000/mm3.
11) Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.
12) Females of childbearing potential (non childbearing is defined as greater than one year post-menopausal or surgically sterilized) must use acceptable contraceptive methods (abstinence, intrauterine device, oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.
1) Patients who have received prior therapy with Genasense, any taxane
or any of cisplatin analogues for systemic disease.
2) Patients whose site of primary melanoma is not in the choroid.
3) Patients who have a current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the prostate or cervix or other cancers treated for cure and with a disease-free survival longer than 2 years.
4) Patients with brain metastasis or history of brain metastasis (es).
5) Patients who are pregnant or breastfeeding.
6) Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
7) Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
8) Patients with unstable or serious concurrent medical conditions are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. PI or his designee shall make the final determination regarding appropriateness of enrollment.
9) Patients with a known hypersensitivity to cremophor containing anti-cancer agents.
10) Patients with one or more of the following as the only manifestations of disease are ineligible: Osteoblastic bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, carcinomatous lymphangitis, CNS metastases, lesions in a previously irradiated area that have not shown definite progression, or disease only inferred from laboratory tests or markers.
11) Patients with Gilbert’s Syndrome.
12) Patients must not have had major surgery within the past 14 days.
13) Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
14) Known HIV disease or infection.
Information and next steps
Sapna P. Patel
Melanoma Medical Oncology
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